FDA & CMS New Programs: What Medtech Startups Need to Know
FDA and CMS just launched two new programs — RAPID and TEMPO — to help innovative medical devices reach patients faster. For startups, this could mean shorter gaps between FDA approval and Medicare coverage, or better ways to build real-world evidence. The catch? These programs only work if you understand them early and plan accordingly.
RAPID: Faster Medicare Coverage After FDA Approval
RAPID, or Regulatory Alignment for Predictable and Immediate Device, targets Class 2 and 3 devices that get FDA’s Breakthrough Device designation*. While Class 2 devices in the RAPID program are required to also participate in the FDA Total Product Life Cycle Advisory Program or TAP**, for Class 3 devices, this is optional. Additionally, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by FDA and CMS.
For eligible devices, the benefit of RAPID is significant: when FDA authorizes your device, CMS aims to decide on Medicare coverage the same day. The “approved but not reimbursed” problem kills momentum in market adoption. RAPID could cut that delay from months (or years) to weeks, making launch planning easier and investor conversations stronger.
TEMPO: Real-World Evidence for Digital Health
TEMPO, or Technology-Enabled Meaningful Patient Outcomes, is a pilot program launched by FDA in connection with the Center for Medicare and Medicaid Innovation (CMMI) for certain digital health devices used in 1 of the 4 CMMI ACCESS clinical use areas: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal and behavioral health.
TEMPO lets companies gather performance data while devices are used by real patients benefiting from care covered by the CMMI ACCESS model. Evidence is expensive. TEMPO offers a structured way to learn from field use, refine products and build stronger FDA cases — all while serving patients.
These programs signal one big change: regulatory, evidence generation and reimbursement planning must happen together, not sequentially.
What to do now:
- Ask: “Does RAPID or TEMPO fit our device?”
- Build evidence strategies that serve both FDA and CMS from day one
- Plan commercialization assuming coverage will matter early
- Don’t wait for perfect clarity — these programs reward early positioning
Where to Learn More
Start with the FDA/CMS RAPID announcement and FDA’s TEMPO materials. They’re dense, but they define eligibility.
At Avio Medtech, we translate programs like these into practical startup strategy. The goal is clarity so you can move faster with confidence. If you need help to plot your course, please reach out.
Clarifications & Additional Information
*The FDA also has a broader lane for innovative devices that don’t qualify for Breakthrough designation, through STeP (Safer Technologies Program). STeP covers devices that significantly improve safety for less serious conditions. More startups could benefit. STeP is designed to help eligible devices get to patients faster by offering more interactive and timely communication with FDA during development and review, while keeping the normal statutory standards for PMA, 510(k) or De Novo pathways. Devices in STeP are not currently eligible for RAPID but still benefit significantly from additional FDA pre-market support.
**While TAP has been around since 2023, the program just (as of May 1, 2026) expanded the eligible therapeutic areas to now also include renal, GI, obesity, transplant, surgical and infection control devices. TAP will expand further on July 1, 2026 to include implantable dental; restorative and surgical dental; ear, nose, and throat; anesthesia; respiratory; sleep disordered breathing; obstetrical and reproductive health, gynecological and surgical, urological, and incontinence and female urological; injection; infusion; general hospital; and in-vitro diagnostic devices.
